# K993239: Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Jan 18, 2000 after 113 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
82 later devices descend from it; 3 cite it directly.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sofamor Danek image guided surgery system: named in the summary without a submission number
- (no number) Zeiss image guided surgery system: named in the summary without a submission number
- (no number) BrainLab image guided surgery system: named in the summary without a submission number

## Most influential descendants
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000 (2006), 50 descendants of its own
- K050615: Stryker Navigation System - CT-Based Hip Module, Model 6007-621-000 (2005), 29 descendants of its own
- K131214: Cranial Map Neuro (2013), 26 descendants of its own
- K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D (2014), 22 descendants of its own
- K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees) (2014), 20 descendants of its own

## Recalls of this device
- Oct 26, 2009 · Not classified · Z-0122-2010: Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or th
- Oct 26, 2009 · Not classified · Z-0123-2010: Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or th
- Sep 8, 2006 · Not classified · Z-0005-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0006-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0007-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Sep 8, 2006 · Not classified · Z-0008-2007: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.

## Indications for use
The Stryker Navigation System — Neuro Module is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery. The system is indicated for any neurological medical condition in which the use of image guided surgery may be appropriate, and where a reference to a rigid anatomical structure can be identified relative to medical images.

Source page: https://510kreport.com/device/K993239
Methodology: https://510kreport.com/methodology